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Once-a-day Immunosuppression(CISECON_a_day) (CISECON)

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ClinicalTrials.gov Identifier: NCT01964014
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : July 21, 2016
Sponsor:
Information provided by (Responsible Party):
Chang kwon oh, Ajou University School of Medicine

Brief Summary:
The objective of this study is to assess the efficacy and safety and Immunosuppressant Therapy Barrier Scale (ITBS) of once daily immunosuppressant maintenance therapy in patients who had kidney transplantations earlier.

Condition or disease Intervention/treatment Phase
Chronic Renal Disease Drug: advagrf Phase 4

Detailed Description:
This is a 6-month, single-arm, multi-center, open-label, continuous cohort study. 160 subjects who had kidney transplantations at least 3 months earlier will participate in the study. All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Investigation for Safety and Efficacy, Patient Reported Outcomes of the Conversion to ONce-a-day Immunosuppression After Kidney Transplantation
Study Start Date : October 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Arm Intervention/treatment
Experimental: advagraf
The same capacity advagaf + sirolimus
Drug: advagrf

All enrolled subjects will discontinue the existing Tacrolimus preparations for 6 months from enrollment and be converted to Extended Release Tacrolimus at a biologically equivalent dose. They will also discontinue enteric-coated mycophenolate sdium or mycophenolate sodium and be treated with Sirolimus and observed.

advagrf+sirolimus one time to eat.





Primary Outcome Measures :
  1. acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up [ Time Frame: 6months ]
    The primary objective of this study is to investigate the efficacy of Advagraf ® (Extended Release Tacrolimus) at 6 months after immunosuppressant conversion to the once daily therapy. The efficacy is defined as the incidence rate of composite endpoints of efficacy failure (acute rejection reaction treated or confirmed by biopsy, loss of graft, death, or lost to follow-up).


Secondary Outcome Measures :
  1. renal functions [ Time Frame: 6months ]
    Difference in renal functions (eGFR by MDRD method), urine protein excretion and P/C ratio (A/C ratio), transplant kidney biopsy histology (if biopsy is performed).

  2. serious adverse events [ Time Frame: 6months ]
    Frequency and severity of adverse events and serious adverse events

  3. cardiovascular health [ Time Frame: 6months ]
    Treatment impact on cardiovascular health: blood pressure and cardiovascular events (acute myocardial infarction, unstable angina pectoris, heart failure, stroke).

  4. NODAT [ Time Frame: 6months ]
    Incidence rate of new onset diabetes after transplantation (NODAT) requiring treatment.

  5. hematology issue [ Time Frame: 6months ]
    Frequency of anemia, leucopenia, and thrombocytopenia.



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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or women at the age of 20 to 65 who had kidney transplantations at least 3 months ago.
  • Recipients of kidney transplantations from a deceased / cadaveric donor, non-heart beating cadaveric donor / organ donor after cardiac death, or non-blood related or blood related live donor.
  • Patients being treated with Tacrolimus or Extended Release Tacrolimus as the existing immunosuppressant maintenance therapy.
  • Able and willing to give informed consent to study participation, having signed the informed consent form according to appropriate procedures, and capable of participating in the study by making visits according to study plans.

Exclusion Criteria:

  • HIV, HBsAg, or anti-HCV test positive patients or having received kidney transplantations from an HIV, HBsAg, or anti-HCV test positive donor.
  • History of severe allergies or hypersensitivities to drugs used in the study or other drugs with a similar chemical structure requiring acute (within the past 4 weeks) or chronic treatment.
  • Having received other investigational product within 30 days prior to enrollment into this study.
  • Women of childbearing potential who plan to become pregnant, pregnant and/or lactating women, women who do not intend to use effective contraceptives.
  • Having uncontrolled diseases or medical conditions requiring continuous treatment.
  • History of alcohol or drug addiction within the past 3 months or incapable of appropriate communications due to reasons such as mental illness.
  • Absolute neutrophil count <1,500/mm3 or leukocyte count <2,500/mm3 or platelet count <75,000/mm3 at screening or severe metabolic disorders (including functional disorders).
  • Having experienced the following condition within the past 1 month:

    • Serum creatinine > 2.0 mg/dl more than twice.
    • 24 hr urine protein≥750 mg/day
    • Diagnosed with or treated for a rejection reaction or an infection or hospitalized due to other medical reasons.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964014


Locations
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Korea, Republic of
Nephrology, Pusan National University Hospital
Busan, Korea, Republic of
Bundang CHA Medical Center,
Gyeonggi-do, Korea, Republic of
Inje University Ilsan Paik Hospital
Gyeonggido, Korea, Republic of
Korea University Medical Center
Seoul, Korea, Republic of
Severance Hospital
Seoul, Korea, Republic of
Soonchunhyang University Hosptial
Seoul, Korea, Republic of
Dept. of Surgery, Ulsan University Hospital
Ulsan, Korea, Republic of
Sponsors and Collaborators
Ajou University School of Medicine
Investigators
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Principal Investigator: chang-kwon oh, M.D.,Ph.D. Ajou University School of Medicine

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Responsible Party: Chang kwon oh, Professor,Department of surgery, Ajou University School of Medicine, Ajou University School of Medicine
ClinicalTrials.gov Identifier: NCT01964014     History of Changes
Other Study ID Numbers: MED-CT4-11-391
First Posted: October 17, 2013    Key Record Dates
Last Update Posted: July 21, 2016
Last Verified: July 2016
Keywords provided by Chang kwon oh, Ajou University School of Medicine:
once
Additional relevant MeSH terms:
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Renal Insufficiency, Chronic
Kidney Failure, Chronic
Kidney Diseases
Urologic Diseases
Renal Insufficiency
Sirolimus
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antineoplastic Agents
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs